MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA (DDQP+); IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3265-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Dyspnea (1816); Hypovolemic Shock (1917); Pleural Effusion (2010); Ventricular Tachycardia (2132); Cardiogenic Shock (2262)

Event Date 05/29/2018

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented to the emergency room complaining of shortness of breath over the past several days.Lung ultrasound showed lung sliding and right sided pleural effusion.Echo showed severely depressed ejection fraction, without pericardial effusion or rhs.Patient was a dni/dnr and rejected intubation.Ventricular tachycardia was observed on the monitor.Patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the primary cause of death was cariogenic shock vs hemorrhagic shock.

• Brand Name: QUADRA ASSURA (DDQP+)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7740834
• MDR Text Key: 115761269
• Report Number: 2017865-2018-11208
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734505673
• UDI-Public: 05414734505673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: CD3265-40Q
• Device Catalogue Number: CD3265-40Q
• Device Lot Number: 4234128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 09/29/2018
• Supplement Dates FDA Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death